title: Budesonide versus prednisone with azathioprine for the treatment of autoimmune hepatitis in children and adolescents.
abstract: OBJECTIVE
  To compare the effect of budesonide vs prednisone therapy both in combination with azathioprine in pediatric patients with autoimmune hepatitis (AIH).
  
  
  METHODS
  Forty-six patients with AIH (11 males and 35 females) aged 9-17 years were enrolled in a 6-month, prospective, double-blind, randomized, active-controlled, multicenter phase IIb study evaluating budesonide (n = 19; 3 mg twice or 3 times daily) vs prednisone (n = 27; 40 mg/day tapered to 10 mg/day), both with azathioprine (1-2 mg/kg/day), followed by a further 6 months of open-label budesonide therapy. The primary efficacy endpoint was complete biochemical remission (normal serum alanine aminotransferase and aspartate aminotransferase levels) without predefined steroid-specific side effects.
  
  
  RESULTS
  We observed no statistically significant difference in the percentage of patients who met the primary endpoint between the budesonide (3 of 19; 16%) and prednisone groups (4 of 27; 15%) after 6 months, nor in the percentage of patients who experienced biochemical remission (budesonide, 6 of 19 [32%]; prednisone, 9 of 27 [33%]), lack of steroid-specific side effects (budesonide, 10 of 19 [53%]; prednisone, 10 of 27 [37%]). The mean weight gain was 1.2 ± 3.5 kg in the budesonide group and 5.1 ± 4.9 kg in the prednisone group (P = .006). A total of 42 patients received open-label budesonide treatment for another 6 months. After 12 months, 46% of these patients achieved complete remission.
  
  
  CONCLUSIONS
  Oral budesonide with azathioprine can induce and maintain remission in pediatric patients with AIH and may be considered an alternative therapy to prednisone. The treatment causes fewer side effects and does not lead to weight gain; however, it may be less effective than prednisone in inducing remission.
authors.affiliation: Children's Health Memorial Institute, Warsaw, Poland. Electronic address: m.woynarowski@czd.pl.
authors.forename: Marek
authors.initials: M
authors.lastname: Woynarowski
authors.forename: Antal
authors.initials: A
authors.lastname: Nemeth
authors.forename: Yaacov
authors.initials: Y
authors.lastname: Baruch
authors.forename: Sibylle
authors.initials: S
authors.lastname: Koletzko
authors.forename: Michael
authors.initials: M
authors.lastname: Melter
authors.forename: Burkhard
authors.initials: B
authors.lastname: Rodeck
authors.forename: Christian P
authors.initials: CP
authors.lastname: Strassburg
authors.forename: Markus
authors.initials: M
authors.lastname: Pröls
authors.forename: Małgorzata
authors.initials: M
authors.lastname: Woźniak
authors.forename: Michael P
authors.initials: MP
authors.lastname: Manns
mesh_terms: D000293:Adolescent; D000410:Alanine Transaminase / Q000097:blood; D001219:Aspartate Aminotransferases / Q000097:blood; D001379:Azathioprine / Q000008:administration & dosage / Q000627:therapeutic use*; D019819:Budesonide / Q000008:administration & dosage / Q000627:therapeutic use*; D002648:Child; D002675:Child, Preschool; D004311:Double-Blind Method; D005260:Female; D005938:Glucocorticoids / Q000008:administration & dosage / Q000627:therapeutic use; D019693:Hepatitis, Autoimmune / Q000188:drug therapy*; D006801:Humans; D007166:Immunosuppressive Agents / Q000008:administration & dosage / Q000627:therapeutic use; D008297:Male; D011241:Prednisone / Q000008:administration & dosage / Q000627:therapeutic use*; D011446:Prospective Studies; D012074:Remission Induction; D016896:Treatment Outcome
chemical_list: D005938:Glucocorticoids; D007166:Immunosuppressive Agents; D019819:Budesonide; D001219:Aspartate Aminotransferases; D000410:Alanine Transaminase; D001379:Azathioprine; D011241:Prednisone
keywords: AIH; ALT; AST; Alanine aminotransferase; Aspartate aminotransferase; Autoimmune hepatitis; NS; Not significant